510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190219Substantially Equivalent

Simplexa VZV Direct, Simplexa VZV Positive Control Pack

DiaSorin Molecular LLC, Cypress CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190219 is the FDA 510(k) clearance record for Simplexa VZV Direct, Simplexa VZV Positive Control Pack, a class II device, cleared for Diasorin Molecular, LLC on under FDA product code PLO (Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System). FDA's definition for product code PLO reads: "A meningitis/encephalitis pathogen multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the direct detection and identification of microbial-associated nucleic acids in cerebrospinal fluid. The test is...". FDA records list 32 510(k) clearances for Diasorin Molecular, LLC, from to . As of , FDA records show one recall naming K190219.

Clearance record

Decision date
Received
(98 days to decision)
Product code
PLO Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
Regulation
21 CFR 866.3970
Device class
Class II
Review panel
Microbiology
Applicant
Diasorin Molecular, LLC 11331 Valley View St., Cypress CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PLO

Trailing 12 months

FDA records hold no clearances under product code PLO in the trailing twelve months.

FDA records show no clearances under product code PLO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PLO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260